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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

Warning Letters issued in 2010

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 08, 2010 Bryant Ranch Prepack Inc. Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
April 08, 2010 Storz Medical, AG Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
April 07, 2010 Wake Forest University Baptist Medical Center Atlanta District Office Device/Adulterated Not Issued *
April 06, 2010 Pure Med Spa Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 06, 2010 Aloha Medicinals Inc. San Francisco District Office New Animal Drug/Labeling/Misbranded/Adulterated Not Issued *
April 05, 2010 Medical Cosmetic Enhancements Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded May 21, 2010
April 05, 2010 All About You Medspa, LLC Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
April 05, 2010 All About You Medspa, LLC Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded May 21, 2010
April 05, 2010 Spa 35 Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded May 21, 2010
April 05, 2010 Monarch Med Spa Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded May 21, 2010
April 05, 2010 Innovative Directions in Health Center for Drug Evaluation and Research Lipdissolve/False & Misleading Claims/Misbranded February 10, 2011
April 05, 2010 7Seas LLC Florida District Office Dietary Supplement Regulations/Misbranded Not Issued *
April 02, 2010 Wright Place, LLC New England District Office Illegal Drug Residue Not Issued *
April 01, 2010 Yurkanin, John B Philadelphia District Office Illegal Drug Residue Not Issued *
April 01, 2010 Deitz, Robert, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 31, 2010 Cut Fruit Express, Inc. Minneapolis District Office CGMP for Foods/HACCP/Adulterated February 08, 2011
March 30, 2010 Coats International Holdings, Inc Dallas District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated Not Issued *
March 30, 2010 Wisconsin Brother's Bakery, Inc Minneapolis District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
March 29, 2010 IVF Phoenix Los Angeles District Office Human Cells, Tissues & Cellular Products July 18, 2011
March 29, 2010 Apotex Inc. Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated July 01, 2011



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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